Label: BIOCORNEUM PLUS BROAD SPECTRUM SPF 30 ADVANCED SCAR TREATMENT GEL- avobenzone,homosalate,meradimate,octisalate,octocrylene gel
-
Contains inactivated NDC Code(s)
NDC Code(s): 71241-004-94, 71241-004-95 - Packager: Sientra, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated September 2, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
-
Warnings
Skin Cancer/Skin Aging Alert:
Spending time in the sun increases
your risk of skin cancer and early skin
aging. This product has been shown
only to help prevent sunburn, not
skin cancer or early skin aging.For external use only.
Do not use on damaged or
broken skin.When using this product keep out
of eyes. Rinse with water to remove.
Stop use and ask a doctor if
rash occurs. - Dosage Form
- DIRECTIONS
- OTHER INFORMATION
- USES
- INACTIVE INGREDIENTS
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN.
- DOSAGE AND ADMINISTRATION SECTION
-
PRINCIPLE DISPLAY SECTION
Biocorneum Advanced Scar Treatment Broad Spectrum SPF 30
For Professional Use Only
NET WT 3.35 fl oz (95g)
BIOCORNEUM by Sientra is
the only advanced scar
treatment with Silishield
patented crosslinked silicone
plus SPF 30 protection.
What is Silishield?
Silishield advances the
benefits of traditional silicone
sheeting through the comfort
and ease of a gel. Patented
crosslinked silicone creates
an invisible shield that feels
like a second skin and helps
reduce the appearance of
scars. It can reduce redness
and discoloration, soften
and flatten new and older
hypertrophic and keloid scars
resulting from surgical
procedures, injuries and burns.
The SPF is designed to be
effective while also maintaining
Silishield’s silky-smooth feel
and clear appearance.
Manufactured in the USA for
Sientra, Inc., Santa Barbara, CA 93117
2021 Sientra, Inc.
sientra.com
BIOCORNEUM and Silishield are
registered trademarks of Sientra, Inc.
May be covered by one or more of
the following U.S. patents:
5,741,509; 8,021,683; 8,802,133;
9,339,546; 9,795,706 -
INGREDIENTS AND APPEARANCE
BIOCORNEUM PLUS BROAD SPECTRUM SPF 30 ADVANCED SCAR TREATMENT GEL
avobenzone,homosalate,meradimate,octisalate,octocrylene gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71241-004 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 10 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 g MERADIMATE (UNII: J9QGD60OUZ) (MERADIMATE - UNII:J9QGD60OUZ) MERADIMATE 5 g in 100 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 15 g in 100 g Inactive Ingredients Ingredient Name Strength DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71241-004-94 1 in 1 CARTON 11/01/2021 1 NDC:71241-004-95 95 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 11/01/2021 Labeler - Sientra, Inc. (010209877) Establishment Name Address ID/FEI Business Operations FORMULATED SOLUTIONS, LLC 143266687 manufacture(71241-004)
